CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 389 enrolled
Drug / intervention
E2007 (perampanel) +2 moredrug
Likely dose
E2007 (perampanel) 8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00699582
NCT00699582Phase 3Completed
CompareCT.gov

A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

Eisai Inc.·interventional·Posted Jun 18, 2008·Updated Jul 11, 2014

In Brief

A Phase 3 clinical trial evaluating E2007 (perampanel) and Placebo for Refractory Partial Seizures. Completed, enrolled 389 participants across 92 sites in 14 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRefractory Partial Seizures
CountriesAustria, Belgium, Finland, France, Germany, India, Israel, Italy, Netherlands, Russia, South Africa, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 18, 2008
Enrollment StartMay 1, 2008
Primary CompletionDec 1, 2010
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 18.0 years ago

Interventions

E2007 (perampanel)drug

8 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.

E2007 (perampanel)drug

12 mg perampanel in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study and will be up-titrated weekly in 2-mg increments to their randomized dose.

Placebodrug

Placebo in a 1:1:1 ratio, 125 subjects/arm. All subjects will take a maximum of 6 tablets daily for the duration of the study.